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Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.

NCT ID: NCT00282620

Last Updated: 2007-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-06-30

Brief Summary

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This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.

Detailed Description

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Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life.

Conditions

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Arrhythmia Quality of Life Hypomagnesemia

Keywords

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Implantable Cardioverter Defibrillator Magnesium Electrocardiogram Ventricular Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Magnesium L-lactate

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hartford Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jeffrey Kluger, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeffrey Kluger, MD

Role: CONTACT

Phone: 860-545-2883

Email: [email protected]

Charles M White, PharmD

Role: CONTACT

Phone: 860-545-2221

Email: [email protected]

Facility Contacts

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Jeffrey Kluger, MD

Role: primary

Charles M White, PharmD

Role: backup

Other Identifiers

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KLUG001817HE

Identifier Type: -

Identifier Source: org_study_id